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Volume 172, Number 1, Part 1 Am J Obstet Gynecol Letters 243 cians in a manner that optimized fetal health and perinatal outcomes? Finally, only 17% of fetal anomalies were detected by the ultrasonographic examinations. This raises a major question regarding quality. Regarding savings, it is assumed that the high-risk patients initially excluded would have had two exami- nations, that the noncompliers or nonparticipants would have had one examination, and that 55% of low-risk patients could forego an examination to no detriment. The savings in the annual obstetric ultra- sonography budget compared with universal screening would be $357,120,000 (23%) or $89.28 per pregnant patient in the United States. Compared with the benefits of a patient knowing early about a multiple gestation or an anomaly, a physician not missing an indication for an ultrasono- graphic examination that would result in a poor out- come, and correcting dates in 11% of even the low-risk patients, the $89.28 is not too great an addition to health care costs. Furthermore, all medicine aside, the patient’s enjoyment of those first glimpses of the fetus may well be worth the money to them. Fatalism is not common in America. Regardless of any cost-benefit analysis on a population, an individual may not and more often will not accept an argument to forego tests on the basis of nonprohibitive expenses when it concerns health. It is our opinion that routine obstetric ultrasonography performed by qualified labo-, ratories is useful and affordable and should become standard of practice. William J. Polzin, MD: and Kim Brady, MD Good Samantan Hospital, 3 75 Dixmyth Ave., Cincinnati, OH 45220 REFERENCE 1. Ewigman BG, Crane JP, Frigoletto FD, et al. Effect of prena- tal ultrasound screening on perinatal outcome. N Engl J Med 1993;329:821-7. m/59757 Reply To the Editors: Polzin and Brady raise several questions about the RADIUS study. The demographic character- istics of the sample were documented in the publica- tions. The principal difference between the sample and the population at large is a higher proportion of white patients and a higher level of education. There is no particular reason to believe that these characteristics would alter the impact of ultrasonographic screening in pregnancy. It is not clear what is implied by the statement “randomization took place after self-selection and com- pliance were tested.” The only process of self-selection was informed consent; this is the ethical standard for the conduct of clinical trials. Compliance was not tested. Indeed, there were patients in the screened group who were noncompliant with their examinations. Again, as is the standard in clinical trials, all patients were analyzed in the group to which they were randomized, regardless of compliance. With respect to exclusions from the study, most met specific indications for ultrasonography, and the results of the study cannot be generalized to this population. This does not weaken the control group or the ability to generalize the results to a population similar to the sample studied. Ultrasonographic examinations performed by physi- cians in their offices or in the hospital outside the confines of the study were discouraged except in emer- gencies but were used by clinicians in the management of their patients. Presumably this information was used in a fashion similar to the information provided by study ultrasonographic examinations. An entire article addressing the issues of screening for fetal anomalies was published in the JOURNAL.’ There are many approaches to dealing with the question of the cost of universal screening. Although our estimates are higher than those of Polzin and Brady, we do not consider $357,120,000 an insignifi- cant cost savings on an annual basis. The benefits alluded to were not substantiated in the largest ran- domized trial of routine ultrasonography to date. This study confirmed the findings of virtually every previous study of ultrasonographic screening. We strongly dis- agree that we should ignore the results of scientific data, ignore the additional cost, and establish ultraso- nographic screening as a standard of practice. Michael LeFeure, MD, and Bernard Ewigman, MD Department of Family and Community Medicine, MA 303 Medical Sciences Bldg., Columbia, MO 65212 6/8/59756 REFERENCE 1. Crane JP, LeFevre ML, Winborn RC, et al. A randomized trial of prenatal ultrasonographic screening: impact on the detection, management, and outcome of anomalous fe- tuses. AM J OBSTET GYNECOL 1994;171:392-9. Invasive fetal monitoring and human immunodeficiency virus transmission To the Editors: We read with great interest the article by Viscarello, et al. (Viscarello RR, Copperman AB, De- Gennaro NJ. Is the risk of perinatal transmission of human immunodeficiency virus increased by the intra- partum use of spiral electrodes or fetal scalp pH sam- pling? AM J OBSTET GYNECOL 1994;170:740-3). The au- thors describe 148 women infected with human immu- nodeficiency virus delivered of infants, 3 1 of whom had either internal fetal scalp monitoring, a fetal scalp pH determination, or both. The authors state “The perina- tal transmission rate for the monitored group was 29.0% and that of the control group was 25.6%.” These differences were not statistically significant. However, if the percentage of individuals requiring internal moni- toring or fetal scalp pH measurement and the rates of human immunodeficiency virus transmission that the authors found are truly representative and can be extrapolated to larger numbers, a different conclusion will be reached. If you multiply the authors’ numbers by

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Volume 172, Number 1, Part 1 Am J Obstet Gynecol

Letters 243

cians in a manner that optimized fetal health and perinatal outcomes? Finally, only 17% of fetal anomalies were detected by the ultrasonographic examinations. This raises a major question regarding quality.

Regarding savings, it is assumed that the high-risk patients initially excluded would have had two exami- nations, that the noncompliers or nonparticipants would have had one examination, and that 55% of low-risk patients could forego an examination to no detriment. The savings in the annual obstetric ultra- sonography budget compared with universal screening would be $357,120,000 (23%) or $89.28 per pregnant patient in the United States.

Compared with the benefits of a patient knowing early about a multiple gestation or an anomaly, a physician not missing an indication for an ultrasono- graphic examination that would result in a poor out- come, and correcting dates in 11% of even the low-risk patients, the $89.28 is not too great an addition to health care costs. Furthermore, all medicine aside, the patient’s enjoyment of those first glimpses of the fetus may well be worth the money to them.

Fatalism is not common in America. Regardless of any cost-benefit analysis on a population, an individual may not and more often will not accept an argument to forego tests on the basis of nonprohibitive expenses when it concerns health. It is our opinion that routine obstetric ultrasonography performed by qualified labo-, ratories is useful and affordable and should become standard of practice.

William J. Polzin, MD: and Kim Brady, MD Good Samantan Hospital, 3 75 Dixmyth Ave., Cincinnati, OH 45220

REFERENCE

1. Ewigman BG, Crane JP, Frigoletto FD, et al. Effect of prena- tal ultrasound screening on perinatal outcome. N Engl J Med 1993;329:821-7.

m/59757

Reply To the Editors: Polzin and Brady raise several questions about the RADIUS study. The demographic character- istics of the sample were documented in the publica- tions. The principal difference between the sample and the population at large is a higher proportion of white patients and a higher level of education. There is no particular reason to believe that these characteristics would alter the impact of ultrasonographic screening in pregnancy.

It is not clear what is implied by the statement “randomization took place after self-selection and com- pliance were tested.” The only process of self-selection was informed consent; this is the ethical standard for the conduct of clinical trials. Compliance was not tested. Indeed, there were patients in the screened group who were noncompliant with their examinations. Again, as is the standard in clinical trials, all patients were analyzed in the group to which they were randomized, regardless of compliance.

With respect to exclusions from the study, most met specific indications for ultrasonography, and the results of the study cannot be generalized to this population. This does not weaken the control group or the ability to generalize the results to a population similar to the sample studied.

Ultrasonographic examinations performed by physi- cians in their offices or in the hospital outside the confines of the study were discouraged except in emer- gencies but were used by clinicians in the management of their patients. Presumably this information was used in a fashion similar to the information provided by study ultrasonographic examinations.

An entire article addressing the issues of screening for fetal anomalies was published in the JOURNAL.’

There are many approaches to dealing with the question of the cost of universal screening. Although our estimates are higher than those of Polzin and Brady, we do not consider $357,120,000 an insignifi- cant cost savings on an annual basis. The benefits alluded to were not substantiated in the largest ran- domized trial of routine ultrasonography to date. This study confirmed the findings of virtually every previous study of ultrasonographic screening. We strongly dis- agree that we should ignore the results of scientific data, ignore the additional cost, and establish ultraso- nographic screening as a standard of practice.

Michael LeFeure, MD, and Bernard Ewigman, MD Department of Family and Community Medicine, MA 303 Medical Sciences Bldg., Columbia, MO 65212

6/8/59756

REFERENCE

1. Crane JP, LeFevre ML, Winborn RC, et al. A randomized trial of prenatal ultrasonographic screening: impact on the detection, management, and outcome of anomalous fe- tuses. AM J OBSTET GYNECOL 1994;171:392-9.

Invasive fetal monitoring and human immunodeficiency virus transmission To the Editors: We read with great interest the article by Viscarello, et al. (Viscarello RR, Copperman AB, De- Gennaro NJ. Is the risk of perinatal transmission of human immunodeficiency virus increased by the intra- partum use of spiral electrodes or fetal scalp pH sam- pling? AM J OBSTET GYNECOL 1994;170:740-3). The au- thors describe 148 women infected with human immu- nodeficiency virus delivered of infants, 3 1 of whom had either internal fetal scalp monitoring, a fetal scalp pH determination, or both. The authors state “The perina- tal transmission rate for the monitored group was 29.0% and that of the control group was 25.6%.” These differences were not statistically significant. However, if the percentage of individuals requiring internal moni- toring or fetal scalp pH measurement and the rates of human immunodeficiency virus transmission that the authors found are truly representative and can be extrapolated to larger numbers, a different conclusion will be reached. If you multiply the authors’ numbers by